Systems and methods for fluid delivery

ABSTRACT

The invention provides for a delivery system including a delivery assembly configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit and priority to, and is aContinuation of, U.S. patent application Ser. No. 16/169,983 filed onOct. 24, 2018 and titled “SYSTEMS AND METHODS FOR FLUID DELIVERY” andwhich issues as U.S. Pat. No. 11,382,833 on Jul. 12, 2022, and whichitself claims benefit and priority to, and is a Continuation-in-Part(CiP) of, International Patent Application PCT/162017/000549 filed onApr. 25, 2017 and titled “MEDICAL DELIVERY SYSTEM”, which itself claimsbenefit and priority to U.S. Provisional Application Ser. No. 62/326,977filed on Apr. 25, 2016 and to U.S. Provisional Application Ser. No.62/474,096 filed on Mar. 21, 2017, the contents of each of such previousapplications of which are hereby incorporated by reference herein intheir entirety.

FIELD OF THE INVENTION

Embodiments of the present invention generally relate to deliverydevices for delivering substances, such as medicaments, and, moreparticularly, to a delivery system including a modular delivery assemblyconfigured to allow delivery of a single dose of a therapeutic agentfrom a Blow-Fill-Seal (BFS) vial to a patient.

BACKGROUND

Every year, millions of people become infected and die from a variety ofdiseases, some of which are vaccine-preventable. Although vaccinationhas led to a dramatic decline in the number of cases of severalinfectious diseases, some of these diseases remain quite common. In manyinstances, large populations of the world, particularly in developingcountries, suffer from the spread of vaccine-preventable diseases due toineffective immunization programs, either because of poorimplementation, lack of affordable vaccines, or inadequate devices foradministering vaccines, or combinations thereof.

Some implementations of immunization programs generally includeadministration of vaccines via a typical reusable syringe. However, inmany situations, particularly in developing countries, theadministration of vaccines occur outside of a hospital and may beprovided by a non-professional, such that injections are given topatients without carefully controlling access to syringes. The use ofreusable syringes under those circumstances increases the risk ofinfection and spread of blood-borne diseases, particularly whensyringes, which have been previously used and are no longer sterile, areused to administer subsequent injections. For example, the World HealthOrganization (WHO) estimates that blood-borne diseases, such asHepatitis and human immunodeficiency virus (HIV), are being transmitteddue to reuse of such syringes, resulting the death of more than onemillion people each year.

SUMMARY

Embodiments of the present invention provide a delivery system thatovercomes the drawbacks of current delivery devices and methods. Inparticular, the delivery system according to some embodiments includes amodular delivery assembly configured to be coupled to a sourcecontaining a fluid agent (e.g., vaccine, drug, medicament, etc.) andfurther facilitate delivery of a single dose of the fluid agent from thesource to a patient. The delivery assembly may be configured to befilled on-site and in the field with a single dose of a fluid agent,while remaining sterile and preventing the potential for contaminationduring the filling process, or may be pre-filled (e.g., duringmanufacture). The delivery assembly may also or alternatively be capableof delivering a fluid agent in a controlled manner and without requiringspecialized skill in administering delivery of such agent.

In particular, the modular delivery assembly in accordance with someembodiments may be configured to be coupled to a source containing afluid agent, including, but not limited to, a Blow-Fill-Seal (BFS) vial.The delivery assembly may include a modular design consisting ofseparately constructed modular components cooperatively arranged andcoupled to one another. The components of the delivery assembly mayinclude, for example, a hub member configured to be securely coupled tothe BFS vial, a one-way valve member positioned within the hub memberand configured to limit fluid flow to an antegrade direction, and aninsert positioned within the hub member and configured to receive andretain an administration member for receiving the fluid agent from theBFS vial and administering the fluid agent into a patient. Theadministration member may include, for example, a needle (forsubcutaneous, intramuscular, intradermal, or intravenous injection ofthe fluid agent) or a nozzle (e.g., spray nozzle to facilitatedispersion of the fluid agent into a spray or a droplet nozzle forformation of droplets).

In some embodiments, the hub member may include a proximal end definingan inlet port and a distal end defining an outlet port and a channelextending entirely from the proximal end to the distal end, therebyproviding a fluid pathway between inlet and outlet ports. The inlet portmay include a specialty, non-standard (non-Luer-type connection)connection fitting configured to be coupled with a correspondingspecialty, non-standard connection fitting of a BFS vial. For example,the inlet port may include recesses, depressions, or complete aperturesof a particular shape or geometry which are shaped and/or sized toreceive correspondingly shaped and/or sized protrusions, projections, orthe like on the BFS vial. In some embodiments, the inlet port mayinclude two opposing apertures on either side of the hub member. The BFSvial may generally include a flexible body having an interior volumesufficient to contain at least one dose of the fluid agent within. TheBFS vial may generally include a neck extending from the body andterminating at a distal end defining an outlet for dispensing the fluidagent upon squeezing of the vial body. In some embodiments, the vial mayinclude two (2) protrusions defined on opposing sides of the neckadjacent to the distal end and having a general shape corresponding tothe apertures on the hub member. Upon a user inserting the distal end ofthe vial into the inlet port of the hub member, for example, theprotrusions may be shaped so as to slide into engagement with thecorresponding apertures but further shaped to prevent withdrawal of theBFS vial from the hub member, thereby effectively locking themselveswithin the apertures and effectively locking the BFS vial intoengagement with the delivery assembly. By securing the vial to the hubmember, a user need only apply force to (i.e., squeeze) the vial body tocause the fluid agent to flow from the vial, through the deliveryassembly, and to the patient.

The specialty, non-standard connection fitting between the hub memberand the BFS vial in some embodiments may allow for only approved sources(e.g., single-dose BFS vials) with a corresponding agent to be used withthe modular delivery assembly described herein, thereby adding a layerof security. For example, the method of delivery is generally dependenton the type of fluid agent to be delivered. For example, somemedicaments are best delivered intravenously while some vaccines arebest delivered intradermally, and yet still, some fluid agents areadministered via droplets or spray. Accordingly, the delivery assemblymay be configured for delivery of a specific fluid agent and thus theconnection fitting on the hub member may be designed so as to onlyaccept and engage a corresponding connection fitting of a BFS vialcontaining that specific fluid agent. Accordingly, the specialtyconnection fitting design described herein may ensure that only thematching BFS vial (which contains the correct fluid agent for thatspecific delivery assembly) is able to be connected to the modulardelivery assembly, thereby ensuring safety and reducing risk.

As previously described, the delivery assembly may include a one-wayvalve and/or an insert within the hub member. The one-way valve may bepositioned, for example, within the within the channel of the hub memberand/or may be configured to limit fluid flow to an antegrade directionfrom the inlet port towards the outlet port, thereby ensuring that fluidflows in a single direction when the vial body is squeezed for delivery.The insert may, in some embodiments, be positioned within the channeladjacent to the outlet of the hub member. The insert may include aproximal end and an opposing distal end and a channel extending entirelythrough the insert from the proximal end to the distal end. The channelof the insert may be in coaxial alignment with the channel of the hubmember, such that the fluid pathway extends entirely from the inlet portof the hub member, through the one-way valve, and through the channel ofthe insert towards the distal end of the insert. The administrationmember (e.g., needle, nozzle, etc.) may be received and retained withinthe channel of the insert, such that, upon delivery of the fluid agentfrom the BFS vial and through the fluid pathway of the deliveryassembly, the fluid agent will flow out of the administration member,thereby allowing for delivery of the fluid agent to the patient.

In some embodiments, the delivery assembly may include a safety coverfor covering the administration member to prevent contamination andfurther reduce the risk of needlestick injuries, and thus reduce thepotential for spreading blood-borne diseases. The delivery assembly maygenerally be packaged and delivered in a fully assembled state,including the safety cover provided over the needle or nozzle.Accordingly, a user does not have to deal with an exposed needle ornozzle when first attaching a BFS vial to the delivery assembly. Rather,the user need only remove the safety cover once the BFS vial has beensecurely attached to the delivery assembly to thereby expose the needleor nozzle for fluid agent delivery. The user may then replace the coveronce delivery is complete.

The modular construction of the delivery assembly allows for rapidmanufacturing reconfigurations of one or more components with minimalcosts to create new delivery assembly configurations that meet specificneeds (i.e., different modes of delivery depending on agent to bedelivered, such as subcutaneous, intramuscular, intradermal, intravenousinjection, spray, or droplet delivery). For example, the hub member andthe one-way valve may remain the same construction (dimensions andmaterial), while the insert may be changed to account for differentneedle sizes and/or nozzle types, depending on the type of deliveryand/or type of fluid agent to be delivered.

The delivery assembly itself may not be not prefilled. As such, thedelivery assembly may not be required to be maintained at a certaintemperature (e.g., two to eight degrees Celsius (2° C.-8° C.)) duringshipment or storage, thus cutting down on the overall costs. Rather thanmaintaining the delivery assembly at a constant temperature, as is thecase with current devices, only the source containing the fluid agent(e.g., single dose supply provided in a BFS vial) need by maintained ata constant temperature. Accordingly, a plurality of empty deliveryassemblies may be shipped and stored, at a reduced cost, and then filleddirectly on-site and on an as-needed basis, such that only thesingle-dose BFS vials need be stored and maintained. Additionally, inthe case that the delivery device is not prefilled, it may be sterilizedat any point prior to being filled with the fluid agent, which furtherimproves the bulk shipping and storage of such devices.

According to some embodiments, the delivery assembly may be configuredto allow delivery of the agent to the patient in a relatively simplemanner, without requiring specialized training for administering theagent. In particular, the delivery assembly may be designed such that aperson administering the fluid agent (e.g., administrator), which couldalso include self-administration, need only position the device upon theadministration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.),and then fully compress the BFS vial body containing the dose of fluidagent, thereby delivering the correct predefined dosage to the patient.The delivery assembly may also or alternatively be configured such that,in the event that a needle is required (i.e., because the deliverymethod is an injection), needle penetration is limited to the correctlength and orientation within the administration site. For example, insome embodiments, the needle may be positioned substantiallyperpendicular relative to a plane along which the distal end of theinsert lies, such that the needle is configured to be inserted into apatient's skin at a substantially perpendicular angle and the distal endof the insert is configured to contact the patient's skin indicatingadequate depth of penetrating for injection of the fluid agent.Accordingly, embodiments of the modular delivery assembly describedherein may not require a trained, skilled healthcare profession foradministration of vaccines or drugs. As such, the delivery assembly maybe particularly useful in situations in which vaccines or drugs arebeing administered in non-healthcare related facilities (e.g., outsideof clinics or hospitals) and given to large numbers of individuals overa short period of time by a non-professional.

BRIEF DESCRIPTION OF THE DRAWINGS

The figures depict embodiments for purposes of illustration only. Oneskilled in the art will readily recognize from the following descriptionthat alternative embodiments of the systems and methods illustratedherein may be employed without departing from the principles describedherein, wherein:

FIG. 1A is a perspective view of BFS vial package according to someembodiments;

FIG. 1B is a perspective close-up view of a portion of a BFS vialpackage according to some embodiments

FIG. 2A and FIG. 2B are right-side views of a fluid delivery systemaccording to some embodiments;

FIG. 2C and FIG. 2D are right-side views of a portion of the fluiddelivery system according to some embodiments;

FIG. 2E is an exploded right-side view of a hub assembly of the fluiddelivery system according to some embodiments;

FIG. 2F is a right-side cross-sectional view of the fluid deliverysystem according to some embodiments;

FIG. 2G is a right-side cross-sectional assembly view of the hubassembly of the fluid delivery system according to some embodiments;

FIG. 2H is a right-side cross-sectional view of the hub assembly of thefluid delivery system according to some embodiments;

FIG. 2I is a right-rear perspective cross-sectional view of the hubassembly of the fluid delivery system according to some embodiments;

FIG. 2J is a right-side perspective cross-sectional view of a portion ofthe fluid delivery system according to some embodiments;

FIG. 2K is a right-side cross-sectional view of a portion of the fluiddelivery system according to some embodiments;

FIG. 2L is a right-front perspective cross-sectional view of a portionof the fluid delivery system according to some embodiments;

FIG. 3A, FIG. 3B, FIG. 3C, FIG. 3D, FIG. 3E, FIG. 3F, FIG. 3G, and FIG.3H are right-front perspective, top, bottom, left, right, front, back,and front cross-sectional views of a modular hub according to someembodiments;

FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, FIG. 4E, FIG. 4F, FIG. 4G, and FIG.4H are right-front perspective, top, bottom, left, right, front, back,and front cross-sectional views of a modular valve according to someembodiments;

FIG. 5A, FIG. 5B, FIG. 5C, FIG. 5D, FIG. 5E, FIG. 5F, FIG. 5G, and FIG.5H are right-front perspective, top, bottom, left, right, front, back,and front cross-sectional views of a modular insert according to someembodiments;

FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, FIG. 6E, FIG. 6F, and FIG. 6G areright-front perspective, top, bottom, left, right, front, and views of amodular BFS vial according to some embodiments;

FIG. 7A, FIG. 7B, FIG. 7C, FIG. 7D, FIG. 7E, FIG. 7F, and FIG. 7G areright-front perspective, top, bottom, left, right, front, and views of amodular BFS vial according to some embodiments;

FIG. 8 is a perspective flow diagram of a method according to someembodiments;

FIG. 9 is a flow diagram of a method according to some embodiments; and

FIG. 10 is a perspective view of variations of hub assemblies accordingto some embodiments.

DETAILED DESCRIPTION I. Introduction

Embodiments of the present invention provide a modular delivery systemthat overcomes the drawbacks of current delivery devices and methods.For example, the delivery system of some embodiments includes a modulardelivery assembly configured to be coupled to a source containing afluid agent (e.g., vaccine, drug, medicament, etc.) and furtherfacilitate delivery of a single dose of the fluid agent from the sourceto a patient. The delivery assembly may be configured to be filledon-site and in the field with a single dose of a fluid agent, whileremaining sterile and preventing the potential for contamination duringthe filling process. The delivery assembly may also or alternatively becapable of delivering the fluid agent in a controlled manner and withoutrequiring specialized skill in administering delivery of such agent.

The delivery assembly in accordance with some embodiments may beconfigured to be coupled to a source containing the fluid agent,including, but not limited to, a BFS vial. The delivery assembly maygenerally include a modular design consisting of separately constructedcomponents cooperatively arranged and coupled to one another. Thecomponents of the delivery assembly may include, for example, a hubmember configured to be securely coupled to the BFS vial, a one-wayvalve member positioned within the hub member and configured to limitfluid flow to an antegrade direction, and/or an insert positioned withinthe hub member and configured to receive and retain an administrationmember for receiving the fluid agent from the BFS vial and administeringthe fluid agent into a patient. The administration member may include,for example, a needle (for subcutaneous, intramuscular, intradermal, orintravenous injection of the fluid agent) or a nozzle (e.g., spraynozzle to facilitate dispersion of the fluid agent into a spray or adroplet nozzle for formation of droplets).

The modular construction of the delivery assembly may allow for rapidmanufacturing reconfigurations of one or more components with minimalcosts to create new delivery assembly configurations that meet specificneeds (i.e., different modes of delivery depending on agent to bedelivered, such as subcutaneous, intramuscular, intradermal, intravenousinjection, spray, or droplet delivery). For example, the hub member andthe one-way valve may remain the same construction (dimensions andmaterial), while the insert may be changed to account for differentneedle sizes and/or nozzle types, depending on the type of deliveryand/or type of fluid agent to be delivered.

The delivery assembly may generally be configured to allow delivery ofthe agent to the patient in a relatively simple manner, withoutrequiring specialized training for administering the agent. Inparticular, the delivery assembly is designed such that a personadministering the fluid agent (e.g., administrator), which could alsoinclude self-administration, need only position the device upon theadministration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.),and then fully compress the BFS vial body containing the dose of fluidagent, thereby delivering the correct predefined dosage to the patient.

The delivery assembly itself may not be prefilled. As such, the deliveryassembly according to some embodiments may not require the maintenanceof a certain temperature (e.g., two to eight degrees Celsius (2° C.-8°C.)) during shipment or storage, thus cutting down on the overall costs.Rather than maintaining the delivery assembly at a constant temperature,as is the case with current devices, only the source containing thefluid agent (e.g., single dose supply provided in a BFS vial) need bymaintained at a constant temperature, for example. Accordingly, aplurality of empty delivery assemblies may be shipped and stored, at areduced cost, and then filled directly on-site and on an as-neededbasis, such that only the single-dose BFS vials need be stored andmaintained. Additionally, in the case that the delivery device is notprefilled, it may be sterilized at any point prior to being filled withthe fluid agent, which further improves the bulk shipping and storage ofsuch devices.

II. Fluid Delivery Systems

Referring initially to FIG. 1A and FIG. 1B, a perspective view of a BFSvial package 102 and a perspective close-up view of a portion of the BFSvial pack or package 102 according to some embodiments are shown. TheBFS vial package 102 may, for example, comprise a plastic and/or othermolded, extruded, and/or formed manifold 104. In some embodiments, themanifold 104 may comprise a plurality of attachment points 106 via whicha plurality of BFS units, containers, and/or vials 110 a-e are connectede.g., via a breakaway detachment design. FIG. 1B depicts an enlargedperspective view of the breakaway detachment design of a first BFS vial110 a. As shown, each BFS vial 110 a-e may contain a single dose offluid agent and, when a user is ready, a single vial such as the firstBFS vial 110 a may be removed from the manifold 104 via a tear-away typeconnection disposed between a first, outlet, or proximate end 110 a-1 ofthe first BFS vial 110 a (the proximate end 110 a-1 being proximate tothe manifold 104 and a second or distal end 110 a-2 being distaltherefrom) and the respective attachment point 106. According to someembodiments as depicted, for example, the proximate end 110 a-1 (e.g.,that may comprise and/or define an outlet; not separately labeled inFIG. 1A and FIG. 1B) of the first BFS vial 110 a may be coupled to themanifold 104 at the attachment point 106. In some embodiments, by simplypulling the desired first BFS vial 110 a away from the attachment point106, a user is able to separate the first BFS vial 110 a from theremaining BFS vials 110 b-e and use only the single dose that isrequired and/or desired, rather than using a larger source of fluidagent (multiple dose syringe or vial; not shown), thereby completelypreventing the risk of contaminating the single source of fluid agentdisposed in the first BFS vial 110 a.

According to some embodiments, each BFS vial 110 a-e may comprise and/ordefine various features such as features molded, formed, cut, glued,and/or otherwise coupled thereto. As depicted in FIG. 1A and FIG. 1B,for example, the first BFS vial 110 a may comprise a neck 112 a (e.g.,near the proximate end 110 a-1) upon which various mating features areformed (or otherwise coupled). In some embodiments, the neck 112 a maycomprise a first exterior radial flange 114 a, a second exterior radialflange 116 a, and/or a mating tab 118 a. According to some embodiments,the mating tab 118 a may comprise a wedge-shaped radial protrusion(e.g., with an incline increasing from near the proximate end 110 a-1and towards the distal end 110 a-2) disposed on, with, or as part of thesecond exterior radial flange 116 a. In some embodiments, the first BFSvial 110 a may comprise a fluid reservoir 120 a in communication withthe neck 112 a. According to some embodiments, the fluid reservoir 120 amay store, house, and/or accept the single dose of fluid and/or may becoupled to a grip plate 122 a. The grip plate 122 a may, for example,comprise a flat element that permits axial force to be applied to thefirst BFS vial 110 a without causing such axial force to be applied tothe fluid reservoir 120 a.

In some embodiments, the package 102 may comprise an indicia imprintingon the manifold 104 itself and/or upon each individual BFS vial 110 a-e(e.g., on the grip plate 122 a of the first BFS vial 110 a). Exemplaryindicia may include, but is not limited to, lot number, expiration date,medication information, security stamp (color changing temperaturesensor to provide indication of whether BFS vials 110 a-e have or havenot been maintained at required temperature), as well as the dose lineprovided on each BF vial 110 a-e. While five (5) BFS vials 110 a-e aredepicted in FIG. 1A as being coupled to the manifold 104, fewer or moreBFS vials 110 a-e may be coupled to the manifold 104 as is or becomesdesirable and/or practicable.

According to some embodiments, because BFS manufacturing tolerances arenot as precise as injection molding and other manufacturing techniques,the configuration of the BFS vials 110 a-e, such as including the firstexterior radial flange 114 a, the second exterior radial flange 116 a,and/or the mating tab(s) 118 a, may permit the BFS vials 110 a-e to becoupled to a modular delivery system (not shown) as described herein,while enabling functionality despite a wide range of manufactureddimensions. In such a manner, for example, reduced costs may be achievedby employing BFS technology while maintaining modular fluid deliveryfunctionality that previous systems could not achieve.

In some embodiments, fewer or more components 104, 106, 110 a-e, 110a-1, 110 a-2, 112 a, 114 a, 116 a, 118 a, 120 a, 122 a and/or variousconfigurations of the depicted components 104, 106, 110 a-e, 110 a-1,110 a-2, 112 a, 114 a, 116 a, 118 a, 120 a, 122 a may be included in theBFS vial package 102 without deviating from the scope of embodimentsdescribed herein. In some embodiments, the components 104, 106, 110 a-e,110 a-1, 110 a-2, 112 a, 114 a, 116 a, 118 a, 120 a, 122 a may besimilar in configuration and/or functionality to similarly named and/ornumbered components as described herein. In some embodiments, the BFSvial package 102 (and/or portion and/or component 104, 106, 110 a-e, 110a-1, 110 a-2, 112 a, 114 a, 116 a, 118 a, 120 a, 122 a thereof) may beutilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9herein, and/or portions or combinations thereof.

Turning now to FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F,FIG. 2G, FIG. 2H, FIG. 2I, FIG. 2J, FIG. 2K, and FIG. 2L, various viewsof a fluid delivery system 200 according to some embodiments are shown.In particular, FIG. 2A and FIG. 2B are right-side views of the fluiddelivery system 200, FIG. 2C and FIG. 2D are right-side views of aportion of the fluid delivery system 200, FIG. 2E is an explodedright-side view of a portion of the fluid delivery system 200, FIG. 2Fis a right-side cross-sectional view of the fluid delivery system 200,FIG. 2G is a right-side cross-sectional assembly view of a portion ofthe fluid delivery system 200, FIG. 2H is a right-side cross-sectionalview of a portion of the fluid delivery system 200, FIG. 2I is aright-rear perspective cross-sectional view of a portion of the fluiddelivery system 200, FIG. 2J is a right-side perspective cross-sectionalview of a portion of the fluid delivery system 200, FIG. 2K is aright-side cross-sectional view of a portion of the fluid deliverysystem 200, and FIG. 2L is a right-front perspective cross-sectionalview of a portion of the fluid delivery system 200.

In some embodiments, the fluid delivery system 200 may comprise variousinter-connected and/or modular components such as a BFS vial 210 (e.g.,having a first end 210-1 and a second end 210-2) comprising and/ordefining a vial neck 212, a first flange 214, a second flange 216, aplurality of locking tabs 218 a-b, a collapsible reservoir 220, and/or agrip plate 222. According to some embodiments, the fluid delivery system200 may comprise a delivery or hub assembly 226 comprising a safetycover or cap 228 (e.g., comprising and/or defining a cylindrical capbody 228-1, an interior void 228-2, a tapered cap body 228-3, and/orhead space 228-4), a hub 230 (e.g., comprising a hub body 232, a hubbore 232-1 defining a hub bore diameter 232-2, a vial bevel 232-3, aplurality of locking slots 234 a-b, an assembly flange 236, a valve slot238, a fluid outlet bore 240 defining a fluid outlet bore diameter240-1, a valve seat 240-2, an insert bore 242 defining an insert borediameter 242-1, an insert bevel 242-2, an insert recess 242-3, and/or aninsert seat 244), a valve 250 (e.g., comprising and/or defining a valvebody 252, a valve channel 252-1, a valve flap 252-2, a mounting wing 254a, a riser 256, an antegrade void 258, a vial flange 260, and seatingsurface 262), an insert 270 (e.g., comprising and/or defining an insertbody 272, a fluid channel 272-1, a channel stop 272-2, an outlet funnel274, an inlet funnel 276, a seating flange 278, and/or a seating flangecollar 278-1), and/or an administration member 280 (e.g., comprisingand/or defining an elongate body 282, a fluid bore 282-1, a first end282-2, a second end 282-3, and/or a needle, point, or tip 284).According to some embodiments, the fluid delivery system 200 and/or thehub assembly 226 may include a modular design consisting of separatelyconstructed components 228, 230, 250, 270, 280 cooperatively arrangedand coupled to one another. The components 228, 230, 250, 270, 280 ofthe hub assembly 226 may include, for example, the hub 230 beingconfigured to be coupled to a source containing the fluid agent,including, but not limited to, the BFS vial 210, a one-way valve 250positioned within the hub 230 and configured to limit fluid flow to anantegrade direction, and the insert 270 positioned within the hub 230and configured to receive and retain the administration member 280 forreceiving the fluid agent from the BFS vial 210 and administering thefluid agent into a patient (not shown).

In some embodiments, the administration member 280 may include theneedle 284 for at least one of subcutaneous, intramuscular, intradermal,and intravenous injection of the fluid agent into the patient. For easeof explanation and description, the figures and the description hereingenerally refer to the administration member 280 as a needle 284.However, it should be noted that, in other embodiments, theadministration member 280 may include a nozzle (not shown) configured tocontrol administration of the fluid agent to the patient. The nozzle mayinclude a spray nozzle, for example, configured to facilitate dispersionof the fluid agent into a spray. Accordingly, a hub assembly 226 fittedwith a spray nozzle may be particularly useful in the administration ofa fluid agent into the nasal passage, for example, or other parts of thebody that benefit from a spray application (e.g., ear canal, otherorifices). In other embodiments, the nozzle may be configured tofacilitate formation of droplets of the fluid agent. Thus, a hubassembly 226 including a droplet nozzle may be useful in theadministration of a fluid agent by way of droplets, such asadministration to the eyes, topical administration, and the like.

As generally understood, the fluid agent may include any type of agentto be injected into a patient (e.g., mammal, either human or non-human)and capable of producing an effect. Accordingly, the agent may include,but is not limited to, a vaccine, a drug, a therapeutic agent, amedicament, or the like.

According to some embodiments, the hub 230 may include a hub body 232defining a hub bore 232-1 having a first end defining an inlet port anda second end defining an outlet, e.g., along an axis “A-A” as depictedin FIG. 2E. In some embodiments, the hub bore 232-1 may provide a fluidpathway between the inlet and outlet ports. The hub 230 may include aspecialty, non-standard (non-Luer-type) connection fitting such as thelocking slots 234 a-b configured to be coupled with a correspondingspecialty, non-standard connection fitting of the BFS vial 210 (shown inFIG. 2A and FIG. 2F) such as the locking tabs 218 a-b. For example, aportion of the hub body 232 adjacent the first end may include recesses,depressions, or complete apertures (e.g., the locking slots 234 a-b) ofa particular shape or geometry which are shaped and/or sized to receivecorrespondingly shaped and/or sized protrusions, projections, or thelike (e.g., the locking tabs 218 a-b) of the BFS vial 210. In someembodiments, the hub body 232 may include two locking slots 234 a-bdefining opposing apertures on either side of the hub body 232 andadjacent to the first end, the locking slots 234 a-b being shaped and/orsized to receive and retain corresponding locking tabs 218 a-b definedon the neck 212 of a BFS vial 210. According to some embodiments, thehub 230 may comprise one or more window or port portions such as thevalve slot 238 formed on the hub body 232 and configured to provide ameans for receiving and retaining a portion (e.g., the mounting wing 254a) of the valve 250 within.

For example, the valve 250 may be generally positioned within the hubbore 232-1 and/or may be formed from a polymer material, such rubber,synthetic rubber, latex, and/or other elastomeric polymer material. Insome embodiments, the valve 250 may be press-fit into the hub bore 232-1such that portions (e.g., the mounting wing 254 a) of the valve 250 mayextend through the valve slot(s) 238 and fill in any gaps so as toprovide at least a watertight seal. The exposed one or more portions ofthe valve 250 (and/or of the mounting wing 254 a thereof) extending tothe outer surface of the hub 230 through the valve slot(s) 238 maygenerally provide a friction fit for an interior surface interior void228-2 of the cap 228 in the case that the cap 228 is placed over and/orcoupled to the hub assembly 226. In other words, the exposed polymermaterial of the valve 250 (and/or of the mounting wing 254 a thereof)may generally provide sufficient friction with the cap 228 so as to keepthe cap 228 retained on to the hub assembly 226. In some embodiments,the valve 250 may comprise and/or define a valve channel 252-1 extendingtherethrough and in coaxial alignment with the hub bore 232-1, e.g.,along axis “A-A”. According to some embodiments, the valve 250 maycomprise a valve flap 252-2 provided within the valve channel 252-1 andconfigured to limit fluid flow to an antegrade direction from the hub230 towards the administration member 280, thereby ensuring that fluidflows in a single direction when the fluid agent is delivered from theBFS vial 210.

In some embodiments, the insert 270 may be positioned within the hubbore 232-1 adjacent to the second end of the hub 230. The insert 270may, according to some embodiments, comprise and/or define a fluidchannel 272-1 extending entirely axially through the insert 270. Thefluid channel 272-1 may be in coaxial alignment with the hub bore 232-1and/or the valve channel 252-1, e.g., along axis “A-A”, such that afluid pathway extends entirely from the first end of the hub 230,through the hub bore 232-1, through the valve channel 252-1 of the valve250, and through fluid channel 272-1 of the insert 270. According tosome embodiments, the seating flange collar 278-1 of the insert 270 maybe configured to be fitted within the valve channel 252-1, e.g., in theriser 256. The administration member 280 (e.g., needle 284) may, in someembodiments, be received and/or retained within the fluid channel 272-1of the insert 270, such that, upon delivery of the fluid agent from theBFS vial 210 and through the fluid pathways of the hub assembly 226, thefluid agent will flow out of the fluid bore 282-1 of the needle 284,thereby allowing for delivery of the fluid agent to the patient.

According to some embodiments, the hub assembly 226 may include the cap228 for covering the needle 284 to prevent contamination and furtherreduce the risk of needlestick injuries, and thus reduce the potentialfor spreading blood-borne diseases. In some embodiments, the hubassembly 226 may generally be packaged and delivered in a fullyassembled state, including the cap 228 provided over the needle 284.Accordingly, a user does not have to deal with an exposed needle 284when first attaching the BFS vial 210 to the hub assembly 226. Rather,the user need only remove the cap 228 once the BFS vial 210 has beensecurely attached to the hub assembly 226 to thereby expose the needle284 for fluid agent delivery. The user may then replace the cap 228 oncedelivery is complete.

In some embodiments, the hub 230, the valve 250, the insert 270, and/orthe cap 228, may be composed of a medical grade material. In someembodiments, the hub 230, the insert 270, and/or cap 228, may becomposed of a thermoplastic polymer, including, but not limited to,polypropylene, polyethylene, polybenzimidazole, acrylonitrile butadienestyrene (ABS) polystyrene, polyvinyl chloride, PVC, or the like.

Referring to FIG. 2A and FIG. 2B, right-side views of the fluid deliverysystem 200 illustrate attachment of the BFS vial 210 to the hub assembly226. As shown in an unassembled state in FIG. 2A, for example, the hubassembly 226 may be urged axially along the axis “A-A” (e.g., to theleft in FIG. 2A) in accordance with the arrow such that it engages withand/or becomes selectively indexed and/or coupled to the BFS vial 210.In some embodiments, the BFS vial 210 may define the collapsiblereservoir 220 that may generally include a flexible body having aninterior volume sufficient to contain at least one dose of the fluidagent within. The BFS vial 210 may, in some embodiments, comprise theneck 212 extending from the body of the collapsible reservoir 220 andterminating at the first end 210-1 defining an outlet for dispensing thefluid agent upon squeezing of the body of the collapsible reservoir 220(e.g., in accordance with the radially inward-pointing arrows of FIG.2F). According to some embodiments, the BFS vial 210 may be formed byBFS technology. BFS technology is a manufacturing technique used toproduce liquid-filled containers. The BFS vial 210 may be formed by BFStechnology, in that the collapsible reservoir 220, the neck 212, andfirst and second ends 210-1, 210-2 are formed, filled within a fluidagent, and sealed in a continuous process without human intervention, ina sterile enclosed area inside a machine. Accordingly, this process canbe used to aseptically manufacture sterile pharmaceutical liquid dosageforms. BFS technology may be particularly attractive in the market, asit reduces personnel intervention making it a more robust method for theaseptic preparation of sterile pharmaceuticals.

According to some embodiments, the hub body 232 may generally include aspecialty, non-standard connection fitting (locking slots 234 a-b)configured to be coupled with a corresponding specialty, non-standardconnection fitting (e.g., locking tabs 218 a-b) of the BFS vial 210. Forexample, the BFS vial 210 may include the two (2) locking tabs 218 a-bdefined on opposing sides of the neck 212 adjacent to the first end210-1 and having a general shape corresponding to the locking slots 234a-b on the hub 230. Upon a user inserting the first end 210-1 of the BFSvial 210 into the hub 230, the locking tabs 218 a-b may be shaped (e.g.,wedge-shaped) so as to slide into engagement with the correspondinglocking slots 234 a-b, respectively, such engagement as illustrated inFIG. 2B and FIG. 2F. FIG. 2F is a perspective view, partly in section,illustrating the BFS vial 210 attached to the hub assembly 226 andshowing engagement between the connection fittings (e.g., locking tabs218 a-b and locking slots 234 a-b) of the BFS vial 210 and the hub 230of the hub assembly 226, respectively. As depicted, the locking tabs 218a-b on the neck 212 of the BFS vial 210 may be in engagement with thecorresponding locking slots 234 a-b of the hub 230. In some embodiments,the locking tabs 218 a-b may be shaped to prevent or inhibit withdrawalof the BFS vial 210 from the hub 230, thereby effectively lockingthemselves within the locking slots 234 a-b and effectively locking theBFS vial 210 into engagement with the hub assembly 226. By securing theBFS vial 210 to the hub assembly 226, a user need only apply force to(e.g., squeeze) the collapsible reservoir 220, e.g., as indicated by thearrows in FIG. 2F, to cause the fluid agent to flow along the axis “A-A”and out of the fluid bore 282-1 at the needle 284, the fluid agenttraveling from the BFS vial 210, through the hub assembly 226 includingthrough the needle 284, and into the patient (not shown).

In some embodiments, a specialty, non-standard connection fittingbetween the hub assembly 226 and the BFS vial 210 allows for onlyapproved sources (e.g., single-dose BFS vials 210) with a correspondingagent to be used with the fluid delivery system 200, thereby adding alayer of security. For example, a method of delivery is generallydependent on the type of fluid agent to be delivered. For example, somemedicaments are best delivered intravenously while some vaccines arebest delivered intradermally, and yet still, some fluid agents areadministered via droplets or spray. Accordingly, the hub assembly 226may be configured for delivery of a specific fluid agent and thus theconnection fitting on the hub assembly 226 may be designed so as to onlyaccept and engage a corresponding connection fitting of a BFS vial 210containing that specific fluid agent. Accordingly, the specialtyconnection fitting design may ensure that only the matching BFS vial 210(which contains the correct fluid agent for that specific deliveryassembly) is able to be connected to the hub assembly 226, therebyensuring safety and reducing risk.

FIG. 2G is an exploded, perspective sectional view of the hub assembly226. FIG. 2H is a perspective sectional view of the hub assembly 226illustrating the components assembled to one another and forming acontinuous fluid pathway there-between and FIG. 2I is anotherperspective sectional view of the hub assembly 226 illustrating thecomponents assembled to one another. As shown, and in accordance withsome embodiments, the hub 230 may comprise and/or define the hub bore232-1 extending therethrough. The hub 230 may also or alternativelycomprise a fluid outlet bore 240 to which the valve 250 and insert 270are coupled. In some embodiments, the riser 256 of the valve 250 may bepositioned on one side of the fluid outlet bore 240 (e.g., on the leftside as-depicted) and the seating flange collar 278-1 of the insert 270may generally protrude through or into the fluid outlet bore 240 (and/orthrough or into the riser 256 of the valve 250) and may be positioned onthe other side of the fluid outlet bore 240 (e.g., on the right sideas-depicted). According to some embodiments, the seating flange collar278-1 of the insert 270 may be received within the valve channel 252-1of the riser 256 of the valve 250 and extend may generally abut thevalve flap 252-2. In some embodiments, the administration member 280comprises the elongate body 282 which may be hollow and/or otherwisedefine the fluid bore 282-1, and/or may comprise a generally bluntsecond end 282-3 and the piercing tip 284 at the first end 282-2. Insome embodiments, the second end 282-3 of the administration member 280may be positioned within the fluid channel 272-1 of the insert 270,wherein the fluid channel 272-1 may comprise the channel stop 272-2 orend portion (e.g., interior flange or tapered to a decreasing diameter)which prevents the second end 282-3 of the administration member 280from traveling too far down the fluid channel 272-1. Once fullyassembled, a fluid pathway may extend entirely through the hub assembly226, from the hub 230 to the tip 284 of the administration member 280,and passing through each of the components therebetween (e.g., throughthe hub 230, the valve 250, and the insert 270).

FIG. 2J is an enlarged, perspective view, partly in section,illustrating the locking engagement between the connection fittings ofthe BFS vial 210 and the hub 230 of the hub assembly 226. In someembodiments, the hub body 232 may generally include a specialty,non-standard connection fitting (locking slots 234 a-b) configured to becoupled with a corresponding specialty, non-standard connection fittingof the BFS vial 210. For example, the BFS vial 210 may include two (2)locking tabs 218 a-b and/or other protrusions or features defined onopposing sides of the neck 212 adjacent to the first end 210-1 andhaving a general shape corresponding to the locking slots 234 a-b on thehub 230. Upon a user inserting the first end 210-1 of the BFS vial 210into the hub 230, the locking tabs 218 a-b may be shaped so as to slideinto engagement with the corresponding locking slots 234 a-b,respectively. As shown, the locking tabs 218 a-b on the neck of the BFSvial 210 may be in engagement with the corresponding locking slots 234a-b of the hub 230. The locking tabs 218 a-b may, in some embodiments,be further shaped to prevent withdrawal of the BFS vial 210 from the hub230, thereby effectively locking themselves within the locking slots 234a-b and effectively locking the BFS vial 210 into engagement with thehub assembly 226.

FIG. 2K and FIG. 2L are enlarged, perspective views, partly in section,illustrating engagement between the first end 210-1 (and outlet) of theBFS vial 210 with the valve 250 of the hub assembly 226 when the BFSvial 210 is securely coupled to the hub assembly 226. By securing theBFS vial 210 to the hub 230, the outlet of the first end 210-1 of theBFS vial 210 is, according to some embodiments, disposed in directalignment (e.g., axial alignment) with the valve flap 252-2 of the valve250. Accordingly, the outlet of the BFS vial 210 may be in direct axialalignment with the fluid pathway (e.g., along axis “A-A”). It should benoted that, due to some minor variations that commonly occur during theBFS manufacturing process, BFS vial dimensions may be imprecise. Forexample, the second end 210-1 of any given BFS vial 210 may havedifferent dimensions when compared to one another (on a microscale). Inorder to compensate for such variation, connection fittings between theBFS vial 210 and the hub 230 further ensure that the first end 210-1 ofthe BFS vial 210 is positioned against and into engagement with thevalve 250 (e.g., the vial flange 260 thereof). In some embodiments, dueto the polymer material of the valve 250, a seal may be created betweenthe first end 210-1 of the BFS vial 210 and the vial flange 260 of thevalve 250, thereby accounting for any imprecise manufacturing of the BFSvial 210.

According to some embodiments, and as depicted in FIG. 2A, the fluiddelivery system 200 may be assembled by application of opposing axialforces that urge the hub assembly 226 onto the BFS vial 210 (inaccordance with the arrow shown). In some embodiments, a user (notshown) may take hold of the grip plate 222 and the hub 230 (and/or thecap 228) and push the BFS vial 210 into the hub bore 232-1 of the hubassembly 226. The grip plate 222 may permit the user to apply an axialforce in the direction of the hub assembly 226 without requiring forceto be applied to the collapsible reservoir 220 (e.g., preventingaccidental expelling of the fluid stored in the collapsible reservoir220). According to some embodiments, the user may apply axial force tothe assembly flange 236 of the hub 230 and an opposing axial force tothe grip plate 222, causing a coupling or mating of the BFS vial 210with the hub assembly 226, e.g., as depicted in FIG. 2B.

Referring to FIG. 2C and FIG. 2D, the cap 228 may be selectively engagedto couple to the hub assembly 226. The hub assembly 226 may be disposedin the interior void 228-2 of the cylindrical cap body 228-1, forexample, and/or the administration member 280 thereof may be disposed inthe head space 228-4 of the tapered cap body 228-3, such that the needle284 is protected and/or shrouded—e.g., for cleanliness and safety. Insome embodiments, an outside diameter of the hub body 232 may be sizedto fit within the interior void 228-2 (e.g., may be configured with anoutside diameter that is smaller than an inside diameter of the interiorvoid 228-2). According to some embodiments, one or more portions of thevalve 250 may extend through the side of the hub body 232 causing alocalized increase in outside diameter of the hub assembly 226. In someembodiments, this localized maximum outside diameter of the hub assembly226 may be configured to provide a transition fit (e.g., an “H7/j6” or“tight fit”) between the hub body 232 and the cap 228, allowing the cap228 to be selectively removed (e.g., as depicted in FIG. 2D) and/orinstalled by hand, as desired. According to some embodiments, such as inthe case that the valve 250 comprises rubber or another frictionalsurface, the friction coefficient of such material and/or a compressionof the material inside of the interior void 228-2 may provide and/orenhance the nature of the fit.

According to some embodiments, and as depicted in the assembly view ofFIG. 2E, the fluid delivery system 200 may comprise a hub assembly 226that is composed of a plurality of modular components such as the hub230, the valve 250, the insert 270, and the administration member 280.As depicted in FIG. 2F, the modular components 230, 250, 270, 280 may becoupled together and attached to a BFS vial 210 to form the fluiddelivery system 200. As depicted in the cross-sectional assembly view ofFIG. 2G, the modular components 230, 250, 270, 280 may be assembledalong an axis “A-A” by alignment and/or coupling of various portionsand/or features thereof. The hub 230 may comprise the hub body 232(which may be substantially cylindrical in some embodiments) that maycomprise and/or define the hub bore 232-1 having an inside hub borediameter 232-2, and/or may define a vial bevel 232-3 that engages withthe BFS vial 210 upon insertion thereof. The first flange 214 of the BFSvial 210 and/or the locking tabs 218 a-b may, for example, extendradially outward beyond the hub bore diameter 232-2 and may accordinglyengage with the side walls of the hub bore 232-1 as they are inserteddeeper into the vial bevel 232-3. In some embodiments, such engagementmay cause the neck 212 of the BFS vial 210 (and/or the first flange 214and/or the locking tabs 218 a-b thereof) to compress radially inwardand/or may cause the hub body 232 to expand radially outward (e.g.,elastically), to allow continued advancement of the BFS vial 210 intothe hub 230, e.g., in accordance with a tight fit and/or interferencefit engagement. According to some embodiments, the radial pressureexerted by forcing the neck 212 of the BFS vial 210 into the hub 230 mayimpart a radial spring effect to the locking tabs 218 a-b such that whenaxial advancement aligns the locking tabs 218 a-b with the correspondinglocking slots 234 a-b, the locking tabs 218 a-b spring radially outwardand into the corresponding locking slots 234 a-b, thereby reducingand/or removing the radial pressure exerted thereon by the differencebetween the interior hub bore diameter 232-2 and the outside diameterand/or radial extents of the locking tabs 218 a-b.

In some embodiments, the hub 230 may comprise the fluid outlet bore 240having a fluid outlet bore diameter 240-1. According to someembodiments, as-depicted in FIG. 2G, the fluid outlet bore diameter240-1 may be smaller than the hub bore diameter 232-2. The difference inthe fluid outlet bore diameter 240-1 and the hub bore diameter 232-2may, for example, provide for and/or define the valve seat 240-2 and/orthe insert seat 244. In some embodiments, the valve 250 may be insertedinto the hub bore 232-1 and may comprise the valve body 252 having anoutside diameter sized to fit within the hub bore 232-1. According tosome embodiments, the diameter of the valve body 252 may be larger thanthe hub bore diameter 232-2 such that the valve 250 must be compressedfor an interference fit into the hub bore 232-1. According to someembodiments, the valve 250 may be seated into the valve seat 240-2and/or the mounting wing 254 a may be engaged to fit within and/orthrough the valve slot 238 in the side wall of the hub body 232, e.g.,creating a water-tight seal between the valve body 252 and the hub body232. In some embodiments, the hub 230 may comprise the insert bore 242having an insert bore diameter 242-1. According to some embodiments, theinsert 270 may comprise the seating flange 278 that may have an outsidediameter larger than the inside diameter of the insert bore 242-1. Axialadvancement or insertion of the insert 270 into the insert bore 242 mayaccordingly cause the seating flange 278 to engage the insert bevel242-2 of the hub 230, which may exert a radially outward force on theinsert bevel 242-2 that may cause the hub body 232 to expand (e.g.,elastically) radially to accommodate the seating flange 238. In someembodiments, the insert recess 242-3 of the hub 230 may be sized toaccommodate the seating flange 238 and accordingly, upon advancement ofthe insert 270 into the insert bore 242 such that the seating flange 238aligns axially with the insert recess 242-3, the insert 270 may snapinto place and the hub body 232 may return to the original diameterthereof. According to some embodiments, the seating flange 278 and/orthe seating flange collar 278-1 may engage with and/or create awater-tight seal with the insert seat 244 in the case that the seatingflange 238 is seated in the insert recess 242-3. In some embodiments,the insert 270 may comprise the inlet funnel 276 configured to funnelfluid traveling in an antegrade direction into the fluid channel 272-1.According to some embodiments, the administration member 280 may beinserted into the insert 270 by entering the outlet funnel 274 andextending into the fluid channel 272-1 up to the channel stop 272-2.

Referring to FIG. 2H and FIG. 2I, the seating and sealing between thehub 230, the valve 250, and the insert 270 is depicted. In FIG. 2H, forexample, the seating flange collar 278-1 of the insert 270 is shownhaving a smaller outside diameter than the inside diameter of the valvechannel 252-1 in the riser 256 of the valve 250, and in the case thatthe seating flange 238 is seated in the insert recess 242-3, the seatingflange collar 278-1 is disposed within the valve channel 252-1 in theriser 256 of the valve 250. In some embodiments, the fit between theseating flange collar 278-1, the riser 256, and the fluid outlet bore240 may be configured to provide for a water-tight seal such that anyfluid directed axially through the valve 250 in an antegrade directionmust pass into the inlet funnel 276 and through the fluid bore 282-1 ofthe administration member 280. As depicted in FIG. 2H and FIG. 2I inaccordance with some embodiments, the valve flap 252-2 may comprise apliant portion of the valve 250 centered in the path of fluid flow andbeing free to bend in an antegrade direction by being unencumbered dueto free space provided between the valve flap 252-2 and the inlet funnel276 of the insert 270 and/or may be permitted to travel into the inletfunnel 276 itself.

Referring to FIG. 2J and FIG. 2K, the mating and/or sealing between theBFS vial 210 and the hub assembly 226 is shown. The first flange 214 ofthe BFS vial 210 is depicted having an outside diameter and/or radialextent equal to or greater than the hub bore diameter 232-1, forexample, thus creating a fluid-tight seal within the hub bore 232. Thesecond flange 216 and/or the locking tabs 218 a-b are depicted as beingseated in the hub 230 and as being shaped to prevent retrograde axialmovement of the BFS vial 210 with respect to the hub 230, by havingfeatures that project radially outward to engage with the side walls ofthe hub body 232. In some embodiments as-depicted, the spatialconfiguration of the locking tabs 218 a-b and the hub bore 232 may causethe first end 210-1 of the BFS vial 210 to contact, coupled with, and/orseat against the vial flange 260 of the valve 250, thereby creating afluid-tight seal therebetween. According to some embodiments, the valve250 may create a seal with the valve seat 240-2 and/or the insert 270(and/or the seating flange 238 thereof) may create a seal with theinsert seat 244. In some embodiments, the valve flap 252-1 may bepositioned over and/or biased against the first end 210-1 of the BFSvial 210 such that it prevents any retrograde flow of fluid into the BFSvial 210. The first end 210-1 of the BFS vial 210 may, as positionedagainst the valve 250 and seated in the vial flange 260 in FIG. 2K forexample, prevent retrograde movement or axial displacement of the valveflap 252-2 in the direction of the BFS vial 210, thereby preventing anyopening in the first end 210-1 of the BFS vial 210 from being uncoveredin response to a any retrograde force (while the valve flap 252-2 isotherwise free to bend or move in an antegrade direction at least by notbeing blocked by any objects in the valve channel 252-1. Such aconfiguration in accordance with some embodiments is depicted in FIG.2L, where the collapsible reservoir 220 may provide fluid via the firstend 210-1 of the BFS vial 210 by such fluid flow forcing an antegradedisplacement of the hinged/flapped valve flap 252-2, while a retrogradeflow would not be possible by nature of the first end 210-1 of the BFSvial 210 blocking or preventing retrograde displacement of the valveflap 252-2.

In some embodiments, fewer or more components 210, 210-1, 210-2, 212,214, 216, 218 a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230,232, 232-1, 232-2, 232-3, 234 a-b, 236, 238, 240, 240-1, 240-2, 242,242-1, 242-2, 242-3, 244, 250, 252, 252-1, 252-2, 254 a, 256, 258, 260,262, 270, 272, 272-1, 272-2, 274, 276, 278, 278-1, 280, 282, 282-1,282-2, 282-3, 284 and/or various configurations of the depictedcomponents 210, 210-1, 210-2, 212, 214, 216, 218 a-b, 220, 222, 226,228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234 a-b,236, 238, 240, 240-1, 240-2, 242, 242-1, 242-2, 242-3, 244, 250, 252,252-1, 252-2, 254 a, 256, 258, 260, 262, 270, 272, 272-1, 272-2, 274,276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284 may be included inthe fluid delivery system 200 without deviating from the scope ofembodiments described herein. In some embodiments, the components 210,210-1, 210-2, 212, 214, 216, 218 a-b, 220, 222, 226, 228, 228-1, 228-2,228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234 a-b, 236, 238, 240,240-1, 240-2, 242, 242-1, 242-2, 242-3, 244, 250, 252, 252-1, 252-2, 254a, 256, 258, 260, 262, 270, 272, 272-1, 272-2, 274, 276, 278, 278-1,280, 282, 282-1, 282-2, 282-3, 284 may be similar in configurationand/or functionality to similarly named and/or numbered components asdescribed herein. In some embodiments, the fluid delivery system 200(and/or portion and/or component 210, 210-1, 210-2, 212, 214, 216, 218a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1,232-2, 232-3, 234 a-b, 236, 238, 240, 240-1, 240-2, 242, 242-1, 242-2,242-3, 244, 250, 252, 252-1, 252-2, 254 a, 256, 258, 260, 262, 270, 272,272-1, 272-2, 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284thereof) may be utilized in accordance with the methods 800, 900 of FIG.8 and/or FIG. 9 herein, and/or portions or combinations thereof.

Turning now to FIG. 3A, FIG. 3B, FIG. 3C, FIG. 3D, FIG. 3E, FIG. 3F,FIG. 3G, and FIG. 3H, right-front perspective, top, bottom, left, right,front, back, and front cross-sectional views of a modular hub 330according to some embodiments are shown. In some embodiments, themodular hub 330 may comprise a modular component of a fluid deliverysystem as described herein. The modular hub 330 may comprise, forexample, a cylindrical hub body 232 defining a hub bore 332-1therethrough, the hub bore 332-1 having an inside hub bore diameter332-2. According to some embodiments, the modular hub 330 may comprise avial bevel 332-3 disposed at an opening of the hub bore 332-1 and/or maycomprise a plurality of locking slots 334 a-b disposed in the sides ofthe hub body 332. In some embodiments, the modular hub 330 may comprisean assembly flange 336 disposed at an opening of the hub bore 332-1and/or may comprise a plurality of valve slots 338 a-b disposed in thesides of the hub body 332.

According to some embodiments, the modular hub 330 may comprise a fluidoutlet bore 340 having an interior fluid outlet bore diameter 340-1. Insome embodiments, a valve seat 340-2 may be formed or disposed in thehub bore 332-1 and/or between the hub bore 332-1 and the fluid outletbore 340. In some embodiments, the modular hub 330 may comprise aninsert bore 342 having an interior insert bore diameter 342-1 and/or maycomprise and/or define an insert bevel 342-2 and/or an insert recess342-3. According to some embodiments, the insert recess 342-3 may defineand/or the insert bore 342 may comprise and/or define an insert seat344.

In some embodiments, as best seen in FIG. 3C, the hub bore 332-1 maycomprise a non-circular cross-section such as an oval, square,rectangle, triangle, and/or other shape such as an “eye” shape as shown.In such a manner, for example, only BFS vials having similarly-shapednecks (not shown) may be inserted into the hub bore 332-1 and/or may beinserted and seated properly seated to form a water-tight seal therein.According to some embodiments, the hub bore diameter 332-2 may be equalto the insert bore diameter 342-1 and/or the fluid outlet bore diameter340-1 may be smaller than either or both of the hub bore diameter 332-2and the insert bore diameter 342-1. In some embodiments, the valve seat340-2 and/or the insert seat 344 may be shaped to accept a valve and aninsert (neither shown), respectively. According to some embodiments, thevalve seat 340-2 may be positioned axially adjacent to the valve slots338 a-b such that a portion of a valve inserted into the hub bore 322-1may seat and/or seal with the valve seat 340-2 while another portion ofthe valve seats within, protrudes into, and/or is otherwise engaged witheach respective valve slot 338 a-b. According to some embodiments, thevial bevel 332-3 and the insert bevel 342-2 may be conically-shapedportions that act upon objects inserted axially therein. In the case apliable and/or compressible object (not shown) having an outsidediameter and/or radial extent that exceeds the hub bore diameter 332-2is urged axially into the hub bore 332-1, for example, the vial bevel332-3 may provide or exert a radially inward opposing force thereon,causing object to compress, retract, and/or deform—e.g., increasingly asthe diameter of the vial bevel 332-3 decreases along the axial insertionpath.

According to some embodiments, fewer or more components 332, 332-1,332-2, 332-3, 334 a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2,342-3, 344 and/or various configurations of the depicted components 332,332-1, 332-2, 332-3, 334 a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1,342-2, 342-3, 344 may be included in the modular hub 330 withoutdeviating from the scope of embodiments described herein. In someembodiments, the components 332, 332-1, 332-2, 332-3, 334 a-b, 336, 338,340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 may be similar inconfiguration and/or functionality to similarly named and/or numberedcomponents as described herein. In some embodiments, the modular hub 330(and/or portion and/or component 332, 332-1, 332-2, 332-3, 334 a-b, 336,338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 thereof) may beutilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9herein, and/or portions or combinations thereof.

Turning now to FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, FIG. 4E, FIG. 4F,FIG. 4G, and FIG. 4H, right-front perspective, top, bottom, left, right,front, back, and front cross-sectional views of a modular valve 450according to some embodiments are shown. In some embodiments, themodular valve 450 may comprise a modular component of a fluid deliverysystem as described herein. The modular valve 450 may comprise, forexample, a cylindrical and/or annular-shaped valve body 452 defining avalve channel 452-1 therethrough, having a valve flap 452-2 disposedtherein, and/or one or more mounting wings 454 a-b protruding radiallyfrom the valve body 452. According to some embodiments, the modularvalve 450 may comprise a cylindrical riser 456 extending axially fromthe valve body 452 and/or an antegrade void 458 formed at the base ofthe riser 456. In some embodiments, the modular valve 450 may comprise avial flange 460 formed and/or disposed on an axial-facing surface of thevalve body 452 and/or may comprise a seating surface 462 disposed and/orformed on an opposite axial-facing surface of the valve body 452.

According to some embodiments, the valve body 452 may be shaped to fitwithin a bore of a modular hub member (not shown). The valve body 452may be substantially cylindrically or circularly-shaped, for example, ormay be “eye” or “almond”-shaped, as depicted in FIG. 4A, FIG. 4B, andFIG. 4C. In some embodiments, the valve flap 452-2 may comprise aportion of pliable material attached along only a portion of acircumference of the interior of the valve channel 452-1 such that itmay be selectively and temporarily axially displaced upon application ofan axial force thereto. In some embodiments, more rigid rubber orplastic compounds may be utilized to construct the valve flap 452-2 suchthat larger amounts of axial force are required to bend the valve flap452-2 and/or such that the valve flap 452-2 may comprise an increasednatural spring-effect that urges or biases the valve flap 452-2 to adefault or “closed” position, e.g., normal to an axis of the modularvalve 450.

In some embodiments, fewer or more components 452, 452-1, 452-2, 454a-b, 456, 458, 460, 462 and/or various configurations of the depictedcomponents 452, 452-1, 452-2, 454 a-b, 456, 458, 460, 462 may beincluded in the modular valve 450 without deviating from the scope ofembodiments described herein. In some embodiments, the components 452,452-1, 452-2, 454 a-b, 456, 458, 460, 462 may be similar inconfiguration and/or functionality to similarly named and/or numberedcomponents as described herein. In some embodiments, the modular valve450 (and/or portion and/or component 452, 452-1, 452-2, 454 a-b, 456,458, 460, 462 thereof) may be utilized in accordance with the methods800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinationsthereof.

Turning now to FIG. 5A, FIG. 5B, FIG. 5C, FIG. 5D, FIG. 5E, FIG. 5F,FIG. 5G, and FIG. 5H, right-front perspective, top, bottom, left, right,front, back, and front cross-sectional views of a modular insert 570according to some embodiments are shown. In some embodiments, themodular insert 570 may comprise a modular component of a fluid deliverysystem as described herein. The modular insert 570 may comprise, forexample, a cylindrical-shaped insert body 572 defining a fluid channel572-1 therethrough, having an outlet funnel 574 and/or an inlet funnel576 disposed at opposing ends thereof. According to some embodiments,the outlet funnel 574 may comprise an inside diameter 574-1 configuredfor various desired fluid delivery applications as described herein(e.g., for acceptance of different gauge needles, nozzles, and/or otherdelivery methods or applications). In some embodiments, the modularinsert 570 may comprise a seating flange 578 and/or a seating flangecollar 578-1. As depicted, the seating flange collar 578-1 may houseand/or define the inlet funnel 576. According to some embodiments, theseating flange 578 may be rounded at the radial extents thereof, such asto facilitate insertion of the seating flange 578 into a bore (notshown) with a smaller diameter than that of the seating flange 578.

In some embodiments, fewer or more components 572, 572-1, 572-2, 574,574-1, 576, 578, 578-1 and/or various configurations of the depictedcomponents 572, 572-1, 572-2, 574, 574-1, 576, 578, 578-1 may beincluded in the modular insert 570 without deviating from the scope ofembodiments described herein. In some embodiments, the components 572,572-1, 572-2, 574, 574-1, 576, 578, 578-1 may be similar inconfiguration and/or functionality to similarly named and/or numberedcomponents as described herein. In some embodiments, the modular insert570 (and/or portion and/or component 572, 572-1, 572-2, 574, 574-1, 576,578, 578-1 thereof) may be utilized in accordance with the methods 800,900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinationsthereof.

Turning now to FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, FIG. 6E, FIG. 6F, andFIG. 6G, right-front perspective, top, bottom, left, right, front, andviews of a modular BFS vial 610 according to some embodiments are shown.The BFS vial 610 may, for example, comprise a generally flask-shapedelement comprising a bottom 610-2 at one end and comprising a neck 612,a distal or first flange 614, a proximate or second flange 616, and/or aplurality of indexing or coupling elements 618 a-b at an opposite endthereof. The first flange 614, second flange 616, and/or couplingelements 618 a-b may, in some embodiments, be operable to mate and/orcouple with a hub assembly for fluid delivery (not shown), as describedherein. In some embodiments, the modular BFS vial 610 may comprise aflask-shaped fluid reservoir 620 disposed between the bottom 610-2 andthe neck 612, and/or a compression foot 622 disposed adjacent to and/orat the bottom 610-2.

According to some embodiments, the flask-shaped fluid reservoir 620 maybe axially compressed and/or collapsed to expel any fluid storedtherein, such as by application of an axial force urging the compressionfoot 622 toward the neck 612. In some embodiments, the flask-shapedfluid reservoir 620 may be advantageously ergonomic by lending itself toeasy operation by a user (not shown) by the user placing two (2) or morefingers (not shown) over the top of the flask-shaped fluid reservoir 620with their thumb (also not shown) disposed beneath the compression foot622 at the bottom 610-2. A squeezing motion compressing the fingerstoward the thumb may then, in some embodiments, compress and/or deformthe flask-shaped fluid reservoir 620 such that it achieves asubstantially disk-shaped collapsed appearance and accordingly reducesthe volume of the flask-shaped fluid reservoir 620 to substantially zeroby expelling substantially all fluid previously stored therein.

In some embodiments, fewer or more components 610-2, 612, 614, 616, 618a-b, 620, 622 and/or various configurations of the depicted components610-2, 612, 614, 616, 618 a-b, 620, 622 may be included in the modularBFS vial 610 without deviating from the scope of embodiments describedherein. In some embodiments, the components 610-2, 612, 614, 616, 618a-b, 620, 622 may be similar in configuration and/or functionality tosimilarly named and/or numbered components as described herein. In someembodiments, the modular BFS vial 610 (and/or portion and/or component610-2, 612, 614, 616, 618 a-b, 620, 622 thereof) may be utilized inaccordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein,and/or portions or combinations thereof.

Turning now to FIG. 7A, FIG. 7B, FIG. 7C, FIG. 7D, FIG. 7E, FIG. 7F, andFIG. 7G, right-front perspective, top, bottom, left, right, front, andviews of a modular BFS vial 710 according to some embodiments are shown.The BFS vial 710 may, for example, comprise an accordion or“concertina”-shaped element comprising a top or outlet 710-1 and abottom 710-2. In some embodiments, the BFS vial 710 may comprise (e.g.,at or adjacent to the outlet 710-1) a neck 712, a distal or first flange714, a proximate or second flange 716, and/or a plurality of indexing orcoupling elements 718 a-b. The first flange 714, second flange 716,and/or coupling elements 718 a-b may, in some embodiments, be operableto mate and/or couple with a hub assembly for fluid delivery (notshown), as described herein. In some embodiments, the modular BFS vial710 may comprise a “concertina”-shaped fluid reservoir 720 a-b disposedbetween the top 710-1 and the bottom 710-2, and/or a compression foot722 disposed adjacent to and/or at the bottom 710-2. In someembodiments, the “concertina”-shaped fluid reservoir 720 a-b maycomprise and/or define a plurality of segments, volumes, and/or lobessuch as an upper or first lobe 720 a and a lower or second lobe 720 bformed and/or joined therebetween. Fewer or more lobes 720 a-b may beutilized in some embodiments.

According to some embodiments, the lobes 720 a-b may be axiallycompressed and/or collapsed to expel any fluid stored therein, such asby application of an axial force urging the compression foot 722 towardthe neck 712 and/or the top 710-1. In some embodiments, the lobes 720a-b may be advantageously ergonomic by lending themselves to easyoperation by a user (not shown) by the user placing two (2) or morefingers (not shown) over the top of the first lobe 720 a with theirthumb (also not shown) disposed beneath the compression foot 722 at thebottom 710-2. A squeezing motion compressing the fingers toward thethumb may then, in some embodiments, compress and/or deform each of thelobes 720 a-b such that they each achieve a substantially disk-shapedcollapsed appearance and accordingly reduce the volume of the“concertina”-shaped fluid reservoir 720 a-b to substantially zero byexpelling substantially all fluid previously stored therein.

In some embodiments, fewer or more components 710-1, 710-2, 712, 714,716, 718 a-b, 720 a-b, 722 and/or various configurations of the depictedcomponents 710-1, 710-2, 712, 714, 716, 718 a-b, 720 a-b, 722 may beincluded in the modular BFS vial 710 without deviating from the scope ofembodiments described herein. In some embodiments, the components 710-1,710-2, 712, 714, 716, 718 a-b, 720 a-b, 722 may be similar inconfiguration and/or functionality to similarly named and/or numberedcomponents as described herein. In some embodiments, the modular BFSvial 710 (and/or portion and/or component 710-1, 710-2, 712, 714, 716,718 a-b, 720 a-b, 722 thereof) may be utilized in accordance with themethods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions orcombinations thereof.

III. Fluid Delivery Methods

FIG. 8 is a perspective flow diagram of a method 800 according to someembodiments. The method 800 may, for example, illustrate an exemplaryuse of the various fluid delivery systems and/or components thereof, asdescribed herein. The process diagrams and flow diagrams describedherein do not necessarily imply a fixed order to any depicted actions,steps, and/or procedures, and embodiments may generally be performed inany order that is practicable unless otherwise and specifically noted.While the order of actions, steps, and/or procedures described herein isgenerally not fixed, in some embodiments, actions, steps, and/orprocedures may be specifically performed in the order listed, depicted,and/or described and/or may be performed in response to any previouslylisted, depicted, and/or described action, step, and/or procedure.

In some embodiments, as shown in FIG. 8, the delivery system may bedelivered with a pack of BFS vials 802 and a corresponding number offully assembled delivery assemblies 826 (e.g., with safety covers 828),at 801. A user may then, according to some embodiments, simply tear awayone of the vials 810 from the pack 802 when ready to deliver the singledose of fluid agent, at 803. In some embodiments, the user may thenattach the removed vial 810 to one of the delivery assemblies 826 bypressing (e.g., axially) them together, e.g., until the vial 810 snaps,clicks, and/or locks into place in the delivery assembly 826, at 805.According to some embodiments, the user may then remove the safety cover828 from the combined vial 810 and delivery assembly 826, therebyexposing the needle 880 (or other appropriate administration member), at807. In some embodiments, the user may then administer the fluid agent(either self-administration or administration to another person), at809. Once finished, the safety cover 828 may be placed back on to thedelivery assembly 826 and the contents can be discarded in theappropriate biohazard waste receptacle, at 811.

The delivery assembly 826 is generally configured to allow delivery ofthe agent to the patient in a relatively simple manner, withoutrequiring specialized training for administering the agent. In someembodiments, the delivery assembly 828 is designed such that a personadministering the fluid agent (e.g., administrator), which could alsoinclude self-administration, need only position the device upon theadministration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.),and then fully compress the BFS vial 810 (and/or a fluid reservoirthereof) containing the dose of fluid agent, thereby delivering thecorrect predefined dosage to the patient. The delivery assembly 826 maybe further configured such that, in the event that a needle 880 isrequired (i.e., because the delivery method is an injection), needlepenetration is limited to the correct length and orientation within theadministration site. For example, in some embodiments, the needle 880 ispositioned substantially perpendicular relative to a plane along whichthe distal end of the insert lies, such that the needle 880 isconfigured to be inserted into a patient's skin at a substantiallyperpendicular angle and the distal end of the insert is configured tocontact the patient's skin indicating adequate depth of penetrating forinjection of the fluid agent.

Accordingly, the delivery assembly 826 may not require a trained,skilled healthcare profession for administration of vaccines or drugs.As such, the delivery assembly 826 may be particularly useful insituations in which vaccines or drugs are being administered innon-healthcare related facilities (e.g., outside of clinics orhospitals) and given to large numbers of individuals over a short periodof time by a non-professional.

Referring now to FIG. 9, a flow diagram of a method 900 according tosome embodiments is shown. The method 900 may comprise, for example,separating a BFS vial from a BFS manifold, at 902. A user may grab anindividual vial and twist or bend it to separate it from the BFSmanifold at one or more preconfigured breakage or junction points, forexample. According to some embodiments, the method 900 may comprisecoupling the BFS vial to a delivery hub, at 904. The coupling maycomprise, for example, applying axial force (e.g., via a grip plate ofthe BFS vial and an assembly flange of the assembly hub) that urges aBFS vial axially into a bore of a modular assembly hub (e.g., asdescribed herein), e.g., until engagement elements integral to the BFSvial click or snap into appropriately indexed retention features of theassembly hub. In some embodiments, the method 900 may comprise removinga safety cap, at 906. Axial force may be applied to separate the capfrom the assembly hub, for example, exposing an administration membersuch as a needle, nozzle, dropper, or the like. According to someembodiments, the method 900 may comprise administering a dose of fluid,at 908. The administration element of the assembly hub may be engagedwith a patient, for example, and a collapsible and integral reservoir ofthe BFS vial may be squeezed (e.g., via application of inward radialforce) to force fluid therefrom. According to some embodiments, thefluid may be forced in an antegrade axial direction such that itdisplaces a valve flap of a one-way valve, thereby allowing the fluid toproceed axially into the administration element and be delivered to thepatient. In some embodiments, the method 900 may comprise replacing thesafety cap, at 910. According to some embodiments, the method 900 maycomprise disposing of the delivery system, at 912. In such a manner, forexample, a low-cost, easily transported and more easily stored fluiddelivery system may be provided that allows unskilled users toadminister and/or self-administer.

IV. Additional Embodiments

FIG. 10 shows perspective views of modular delivery or hub assemblies1026 a-d configured for different methods of delivery (e.g.,intramuscular, subcutaneous, intravenous, and intradermal injection). Insome embodiments, each modular hub assembly 1026 a-d may comprise arespective modular hub element 1030 a-d, a modular valve element 1050a-d, a modular insert element 1070 a-d, and/or a modular needle (orother administration) element 1080 a-d. As depicted in FIG. 10, thevarious respective needle elements 1080 a-d may be configured fordifferent delivery/administration requirements. For example, the needleelements 1080 a-d may have varying lengths in the range of about one andone half millimeters (1.5 mm) to twenty-five millimeters (25 mm)—e.g.,with a first needle element 1080 a being the longest, a second needleelements 1080 b being shorter than the first needle element 1080 a, athird needle elements 1080 c being shorter than the second needleelement 1080 b, and/or a fourth needle elements 1080 d being shorterthan the third needle element 1080 c. According to some embodiments,lengths of the needle elements 1080 a-d may be in the range of one halfmillimeter (0.5 mm) to fifty millimeters (50 mm). In some embodiments,the only structural differences between the various hub assemblies 1026a-d may be the lengths (and/or thicknesses) of the needle elements 1080a-d. Each of the other modular components 1030 a-d, 1050 a-d, 1070 a-dmay, for example, be identical. Accordingly, the modular construction ofthe delivery assemblies 1026 a-d may allow for rapid manufacturingreconfigurations of one or more components with minimal costs to createnew delivery assembly configurations that meet specific needs (i.e.,different modes of delivery depending on agent to be delivered, such assubcutaneous, intramuscular, intradermal, intravenous injection, spray,or droplet delivery). For example, the modular hub element 1030 a-d andthe modular valve element 1050 a-d may remain the same construction(dimensions and material), while the modular insert element 1070 a-d maybe changed to account for different sized needle elements 1080 a-dand/or nozzle types, depending on the type of delivery and/or type offluid agent to be delivered.

V. Rules of Interpretation

Throughout the description herein and unless otherwise specified, thefollowing terms may include and/or encompass the example meaningsprovided. These terms and illustrative example meanings are provided toclarify the language selected to describe embodiments both in thespecification and in the appended claims, and accordingly, are notintended to be generally limiting. While not generally limiting andwhile not limiting for all described embodiments, in some embodiments,the terms are specifically limited to the example definitions and/orexamples provided. Other terms are defined throughout the presentdescription.

Numerous embodiments are described in this patent application, and arepresented for illustrative purposes only. The described embodiments arenot, and are not intended to be, limiting in any sense. The presentlydisclosed invention(s) are widely applicable to numerous embodiments, asis readily apparent from the disclosure. One of ordinary skill in theart will recognize that the disclosed invention(s) may be practiced withvarious modifications and alterations, such as structural, logical,software, and electrical modifications. Although particular features ofthe disclosed invention(s) may be described with reference to one ormore particular embodiments and/or drawings, it should be understoodthat such features are not limited to usage in the one or moreparticular embodiments or drawings with reference to which they aredescribed, unless expressly specified otherwise.

Devices that are in communication with each other need not be incontinuous communication with each other, unless expressly specifiedotherwise.

A description of an embodiment with several components or features doesnot imply that all or even any of such components and/or features arerequired. On the contrary, a variety of optional components aredescribed to illustrate the wide variety of possible embodiments of thepresent invention(s). Unless otherwise specified explicitly, nocomponent and/or feature is essential or required.

Further, although process steps, algorithms or the like may be describedin a sequential order, such processes may be configured to work indifferent orders. In other words, any sequence or order of steps thatmay be explicitly described does not necessarily indicate a requirementthat the steps be performed in that order. The steps of processesdescribed herein may be performed in any order practical. Further, somesteps may be performed simultaneously despite being described or impliedas occurring non-simultaneously (e.g., because one step is describedafter the other step). Moreover, the illustration of a process by itsdepiction in a drawing does not imply that the illustrated process isexclusive of other variations and modifications thereto, does not implythat the illustrated process or any of its steps are necessary to theinvention, and does not imply that the illustrated process is preferred.

The present disclosure provides, to one of ordinary skill in the art, anenabling description of several embodiments and/or inventions. Some ofthese embodiments and/or inventions may not be claimed in the presentapplication, but may nevertheless be claimed in one or more continuingapplications that claim the benefit of priority of the presentapplication. Applicants intend to file additional applications to pursuepatents for subject matter that has been disclosed and enabled but notclaimed in the present application.

It will be understood that various modifications can be made to theembodiments of the present disclosure herein without departing from thescope thereof. Therefore, the above description should not be construedas limiting the disclosure, but merely as embodiments thereof. Thoseskilled in the art will envision other modifications within the scope ofthe invention as defined by the claims appended hereto.

While several embodiments of the present disclosure have been describedand illustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and/or structures for performing thefunctions and/or obtaining the results and/or one or more of theadvantages described herein, and each of such variations and/ormodifications is deemed to be within the scope of the presentdisclosure. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present disclosure is/are used.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the disclosure described herein. It is, therefore, to beunderstood that the foregoing embodiments are presented by way ofexample only and that, within the scope of the appended claims andequivalents thereto, the disclosure may be practiced otherwise than asspecifically described and claimed. The present disclosure is directedto each individual feature, system, article, material, kit, and/ormethod described herein. In addition, any combination of two or moresuch features, systems, articles, materials, kits, and/or methods, ifsuch features, systems, articles, materials, kits, and/or methods arenot mutually inconsistent, is included within the scope of the presentdisclosure.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Other elements may optionallybe present other than the elements specifically identified by the“and/or” clause, whether related or unrelated to those elementsspecifically identified, unless clearly indicated to the contrary.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

Various modifications of the invention and many further embodimentsthereof, in addition to those shown and described herein, will becomeapparent to those skilled in the art from the full contents of thisdocument, including references to the scientific and patent literaturecited herein. The subject matter herein contains important information,exemplification and guidance that can be adapted to the practice of thisinvention in its various embodiments and equivalents thereof.

What is claimed is:
 1. A delivery system for delivery of a fluid agent,the delivery system comprising: a blow-fill-seal (BFS) vial containing asingle dose of a fluid agent, the BFS vial defining a cylindrical neckand comprising at least one shaped radial protrusion; and a deliveryassembly configured to be securely coupled to said BFS vial and todeliver said single dose of said fluid agent, said delivery systemcomprising: a hub member having a proximal end defining an inlet portand a distal end defining an outlet port and a channel providing a fluidpathway from said inlet port to said outlet port, said inlet port havinga connection fitting configured to receive and retain the shaped radialprotrusion of the BFS vial thereto, said inlet port configured toreceive the fluid agent from the BFS vial; and an administration memberfor administering said fluid agent into a patient, said administrationmember being retained by the hub member.
 2. The delivery system of claim1, wherein said BFS vial has an interior volume configured to expel saidfluid agent into said fluid pathway and through said channel of saidinsert member and into said administration member in response to acompression force applied thereto.
 3. The delivery system of claim 1,wherein said administration member comprises a needle for at least oneof subcutaneous, intramuscular, intradermal, and intravenous injectionof said fluid agent into said patient.
 4. The delivery system of claim3, wherein said needle is a micro-needle having a length in the range of0.5 mm to 4 mm.
 5. The delivery system of claim 3, wherein said needlehas a length in the range of 4 mm to 15 mm.
 6. The delivery system ofclaim 3, wherein said needle has a length in the range of 15 mm to 30mm.
 7. The delivery system of claim 1, wherein said administrationmember comprises a nozzle configured to control administration of saidfluid agent to said patient.
 8. The delivery system of claim 7, whereinsaid nozzle is configured to facilitate dispersion of said fluid agentinto a spray.
 9. The delivery system of claim 7, wherein said nozzle isconfigured to facilitate dispersion of said fluid agent into one or moredroplets.
 10. The delivery system of claim 1, wherein said connectionfitting of said hub member comprises at least one of a recess,depression, and aperture defined on a portion of said inlet port. 11.The delivery system of claim 1, wherein an interior volume of said BFSvial is in the range of 0.05 ml to 15.0 ml.
 12. A modular injectabledelivery system for injection of a fluid agent from a BFS vial into apatient, the modular injectable delivery system comprising: anadministration member for injecting the fluid agent into the patient,the administration member comprising a needle defining a distal end anda proximate end, the distal end comprising a point for piercing thepatient; and a fluid delivery hub defining a cylindrical body comprisinga first end and a second end, wherein the second end retains theadministration member, the fluid delivery hub defining a bore betweenthe first and second ends, and comprising a plurality of aperturesformed within the bore proximate to the first end thereof, the bore atthe first end being shaped to receive a neck of the BFS vial, whereinthe BFS vial comprises a plurality of external radially projectingmating features and wherein the BFS vial contains the fluid agent, andthe plurality of apertures being shaped to receive the plurality ofexternal radially projecting mating features of the BFS vial.
 13. Themodular injectable delivery system of claim 12, further comprising: aremovable cap selectively coupled to cover the distal end of the needle.14. The modular injectable delivery system of claim 12, wherein a neckof the BFS vial is cylindrically shaped, in fluid communication with afluid reservoir containing the fluid agent, and comprises a seal at anend thereof.
 15. The modular injectable delivery system of claim 14,wherein the fluid reservoir defines an interior volume configured toexpel the fluid agent into the administration member in response to acompression force applied thereto.
 16. The modular injectable deliverysystem of claim 12, wherein the administration member comprises a needlefor at least one of subcutaneous, intramuscular, intradermal, andintravenous injection of said fluid agent into said patient.
 17. Themodular injectable delivery system of claim 16, wherein the needle is amicro-needle having a length in the range of 0.5 mm to 4 mm.
 18. Themodular injectable delivery system of claim 16, wherein the needle has alength in the range of 4 mm to 15 mm.
 19. The modular injectabledelivery system of claim 16, wherein the needle has a length in therange of 15 mm to 30 mm.
 20. The modular injectable delivery system ofclaim 12, wherein the administration member comprises a nozzleconfigured to control administration of the fluid agent to the patient.21. The modular injectable delivery system of claim 20, wherein thenozzle is configured to facilitate dispersion of the fluid agent into aspray.
 22. The modular injectable delivery system of claim 20, whereinthe nozzle is configured to facilitate dispersion of the fluid agentinto one or more droplets.
 23. The modular injectable delivery system ofclaim 12, further comprising: the BFS vial.